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A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic

Primary Purpose

Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

fenofibrate

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Lipid Regulating Agents, Drug Therapy, cardiovascular diseases, hypertriglyceridemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, fenofibrate, Dyslipidemias, Combination

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥18 years and < 80 years, male or female
With at least one risk of coronary heart disease (CHD) [medical history of myocardial infarction (MI) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (PCI) or post coronary artery bypass grafting (CABG)] or CHD risk equivalents, which comprise,
- Other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease)
- Type 2 Diabetes
- Multiple risk factors that confer a 10-year risk for CHD >20%.
≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin
Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG<5.65 mmol/L (500mg/dl)
Subject must be able to provide informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), on his or her own behalf, prior to any study-specific procedures.

Exclusion Criteria:

Hypersensitive to fenofibrate or to any of its excipients
Hepatic insufficiency [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2ULN (upper limit of normal)]
Renal insufficiency [Creatinine clearance rate (Ccr)<60ml/min estimated from Cockcroft-Gault equation Ccr=(140-age)*weight(Kg)*0.85(if female)/[0.818*Cr (µmol/L)]
Creatine kinase (CK) > 2 ULN
Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency
Hypothyroidism
Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months
Combination use of drug with similar structure as Fenofibrate, especially ketoprofen
Combination use of oral anticoagulants
Pregnant or lactating woman
Other conditions at investigator's discretion

Sites / Locations

Site Reference ID/Investigator# 64695

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fenofibrate arm

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Triglyceride (TG) Change

Blood tests

Secondary Outcome Measures

Change in Serum Total Cholesterol

Blood tests

Change in Serum Low-density Lipoprotein Cholesterol

Blood tests

Change in Serum High-density Lipoprotein Cholesterol

Blood tests

Change in Serum Non-high-density Lipoprotein Cholesterol

Blood tests

Change in Serum Apolipoprotein A1

Blood tests

Change in Serum Apolipoprotein B

Blood tests

Change in Serum Alanine Aminotransferase

Blood tests

Change in Serum Aspartate Aminotransferase

Blood tests

Change in Serum Creatine Kinase

Blood tests

Change in Serum Creatinine

Blood tests

Change in Serum High Sensitivity C-reactive Protein

Blood tests

Full Information

NCT ID

NCT01462877

First Posted

October 28, 2011

Last Updated

February 25, 2015

Sponsor

Abbott

Collaborators

Rundo International Pharmaceutical Research & Development Co.,Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01462877

Brief Title

A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic

Official Title

An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

Collaborators

Rundo International Pharmaceutical Research & Development Co.,Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy. According to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. The purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.

Detailed Description

It is an open-label , single group, multi-center study. At around 30 investigate sites, 500 dyslipidemic Chinese patients with coronary heart disease (CHD) or CHD risk equivalent, whose TG ≥1.70 mmol/L (150mg/dl) and <5.65mmol/L (500mg/dl) after at least 2 month statin monotherapy with standard dose will be enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG will be recruited and given statin-fenofibrate combination therapy for 8 weeks. Several lipid parameters and safety parameters will be compared between baseline, after 4 weeks treatment and after 8 weeks treatment. Primary efficacy endpoint is the percentage of TG decrease before and after 8 weeks treatment. Secondary endpoints on efficacy are the absolute change and the percent of change on TC, LDL-C, HDL-C, apoA1, apoB and apoB/apoA1 of baseline, after 4 weeks treatment and 8 weeks treatment, absolute change and percentage of change of hsCRP from baseline to 8 weeks of treatment. Second endpoints on safety is the incidence of AE/SAE, change on CK, ALT, AST, BUN and Cr before and after treatment and the number of clinical meaningful abnormal change defined as ALT or AST >3ULN, or CK >10ULN, or BUN >1.5ULN or Cr >1.5ULN. Other Arm type is a self comparator

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia

Keywords

Lipid Regulating Agents, Drug Therapy, cardiovascular diseases, hypertriglyceridemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, fenofibrate, Dyslipidemias, Combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

506 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fenofibrate arm

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

fenofibrate

Other Intervention Name(s)

ABT-799, lipanthyl

Intervention Description

Fenofibrate Capsule 200mg qd orally

Primary Outcome Measure Information:

Title

Percentage of Triglyceride (TG) Change

Description

Blood tests

Time Frame

Baseline and up to 8 weeks after intervention

Secondary Outcome Measure Information:

Title

Change in Serum Total Cholesterol

Description

Blood tests

Time Frame

Baseline and up to 8 weeks after intervention

Title

Change in Serum Low-density Lipoprotein Cholesterol

Description

Blood tests

Time Frame